RESEARCH
Clinical effectiveness of health visitor training in
psychologically informed approaches for depression in
postnatal women: pragmatic cluster randomised trial in
primary care
C Jane Morrell, senior research fellow ,1 Pauline Slade, professor of clinical psychology,2 Rachel Warner,
consultant psychiatrist,3 Graham Paley, nurse research fellow and psychotherapist,4 Simon Dixon, senior
lecturer in health economics,1 Stephen J Walters, senior lecturer in medical statistics,1 Traolach Brugha,
professor of psychiatry,5 Michael Barkham, director,6 Gareth J Parry, assistant professor,7 Jon Nicholl,
director of medical care research unit1
ABSTRACT
Objective To evaluate benefits for postnatalwomenof two
psychologically informed interventions by health visitors.
Design Prospective cluster trial randomised by general
practice, with 18 month follow-up.
Setting 101 general practices in Trent, England.
Participants 2749 women allocated to intervention, 1335
to control.
Intervention Health visitors (n=8963 clusters) were
trained to identify depressive symptoms at six to eight
weeks postnatally using the Edinburgh postnatal
depression scale (EPDS) and clinical assessment and also
trained in providing psychologically informed sessions
based on cognitive behavioural or person centred
principles for an hour a week for eight weeks. Health
visitors in the control group (n=4938 clusters) provided
usual care.
Main outcome measures Score ≥12 on the Edinburgh
postnatal depression scale at six months. Secondary
outcomes were mean Edinburgh postnatal depression
scale, clinical outcomes in routine evaluation-outcome
measure (CORE-OM), state-trait anxiety inventory (STAI),
SF-12, and parenting stress index short form (PSI-SF)
scores at six, 12, 18 months.
Results 4084 eligible women consented and 595 women
had a six week EPDS score ≥12. Of these, 418 had EPDS
scores available at six weeks and six months. At six
months, 34% women (93/271) in the intervention group
and 46% (67/147) in the control group had an EPDS score
≥12. The odds ratio for score ≥12 at six months was 0.62
(95% confidence interval 0.40 to 0.97, P=0.036) for
women in the intervention group comparedwithwomen in
the control group. After adjustment for covariates, the
odds ratio was 0.60 (0.38 to 0.95, P=0.028). At six
months, 12.4% (234/1880) of all women in the
intervention group and 16.7% (166/995) of all women in
the control group had scores ≥12 (0.67, 0.51 to 0.87,
P=0.003). Benefit for women in the intervention group
with a six week EPDS score ≥12 and for all women was
maintained at 12 months postnatally. There was no
differential benefit for either psychological approach over
the other.
Conclusion Training health visitors to assess women,
identify symptoms of postnatal depression, and deliver
psychologically informed sessions was clinically effective
at six and 12 months postnatally compared with usual
care.
Trial registration ISRCTN92195776.
INTRODUCTION
Postnatal depression is a global problem and an
important public health issue. About 13% of women
experience depression during the first postnatal year,1
yet there are problems in recognition because its
clinical assessment is complex. There can be serious
consequences for the mother, her child,2 and family
and a risk of suicide (the leading cause of maternal
death in England and Wales) and infanticide in some
severely depressed mothers.3 Fathers are also more
likely to be depressed if their partner is depressed,4 and
the children of fathers who experience depression in
the postnatal period are at increased risk of behaviour
problems.5
In primary care, psychological interventions are as
clinically effective in the management of depression as
routine care from a general practitioner or anti-
depressants in the short term and might be cost
effective.6-10 There are problems in treating postnatal
women with antidepressants11 and psychological
therapies provide a practical alternative12 and are
preferred bywomen.13 In theUnitedKingdom the role
of health visitors in managing postnatal depression has
been promoted.14
Cochrane and other reviews covering studies world-
wide have examined interventions for postnatal
depression.15 16 They found insufficient good evidence
1School of Health and Related
Research (ScHARR), University of
Sheffield, Sheffield S1 4DA
2Clinical Psychology Unit,
Department of Psychology,
University of Sheffield, Western
Bank, Sheffield S10 2UR
3Adult Mental Health Services,
Sheffield S11 9AR
4Leeds Mental Health Trust
Specialist Psychotherapy Service,
Leeds LS2 9PJ
5Department of Health Sciences,
University of Leicester, Leicester
General Hospital, Leicester
LE5 4PW
6Centre for Psychological Services
Research, Department of
Psychology, University of
Sheffield, Sheffield S10 2TP
7Department of Pediatrics,
Harvard Medical School,
Children’s Hospital Boston, 300
Longwood Avenue, MA 02115
Correspondence to: C J Morrell,
Centre for Health and Social Care
Research, Human and Health
Sciences, University of
Huddersfield, Queensgate,
Huddersfield HD1 3DH
j.morrell@hud.ac.uk
Cite this as: BMJ 2009;338:a3045
doi:10.1136/bmj.a3045
BMJ | ONLINE FIRST | bmj.com page 1 of 10

to recommend treatment, mainly because of inade-
quacies in design or reporting of random allocation
method, sample size, follow-up, or failure to use
intention to treat analysis. Psychosocial and psycholo-
gical interventions might be an effective treatment
option, but the long term effectiveness remains
unclear.16
In this pragmatic trial we examined outcomes for
postnatal women of special training for health visitors
compared with usual care. We chose a cluster
allocation by general practice to minimise contamina-
tion between intervention and control group. We
tested the hypotheses that there would be no differ-
ences between the groups in outcome for mother,
infant, or family norbetween the groups randomised to
the two different psychological approaches.
METHODS
Setting and participants
The pragmatic cluster trial took place from April 2003
to March 2006 in 101 general practices (clusters) in 29
primary care trusts in the former Trent Regional
Health Authority, comprising a blend of urban and
rural areas, with a population of about 5.2 million
people. Clusters were eligible if they were based in the
Trent region. Health visitors recruited eligible women
antenatally if they were registered with participating
practices, were aged 18 or more, were able to give
informed consent, and had no severe mental health
problems. In 101 clusters there were 7649 eligible
women, and 4084 consented to take part.
Health visitor training
Health visitors in the intervention group were trained
to identify depressive symptoms using the Edinburgh
postnatal depression scale (EPDS)17 and to use clinical
assessment skills to assess a mother’s mood including
suicidal thoughts. The EPDS is a self report measure
with a score ranging from0 to 30 (the highest symptom
level). It is widely used in research and clinical practice
but on its own is inadequate for confirming depression
without a clinical interview. These health visitors were
also trained to deliver psychologically informed
sessionsbasedondistinctpsychological theories, either
cognitivebehaviouralprinciples18oronpersoncentred
principles.19 We then compared these two approaches.
Baseline measurement and identification of women with
six week score ≥12
Women were sent a postal questionnaire at six weeks
postnatally to collect demographic details, measure
depressive symptoms using the EPDS, and measure
social support and stressful life events using the
measure of social relationships20 and list of threatening
experiences,21 and previous depression.22
Administration of the questionnaire coincided with
an existing health visitor contact. We used the
recommended pragmatic EPDS threshold score of 12
to identifywomenwith symptoms of depression.23 24 In
the first validation study, this score correctly identified
all womenwithmajor depression andmost withminor
depression.17 The sensitivity for identifying depressed
women (true positives) was 86% and the specificity for
identifying true negatives was 78%. A cut off of 9 or 10
correctly identified all women with definite minor
depression but the original researchers considered that
there would be an untenable workload for health
visitors if health visitors used this lower threshold.23 As
some women could simply be unhappy when they
completed the six week EPDS, women with a raised
score completed a repeat EPDS after two weeks to
identify those who needed further support.24
We used the recommended score17 to identify
women more likely to benefit from psychologically
informed sessions. Themain comparison was between
women in the twogroupswith anEPDS score≥12 at six
weeks.
We also followed up all consented women as some
who scored <12 at six weeks might have been
depressed at that time and others would have devel-
oped depression over the following months. All
women whose infants were 6, 12, and 18 months old
241 interested clusters (140 clusters did not consent)
101 clusters consented and enrolled 7649 eligible women
Control group (38 clusters) Intervention group (63 clusters)
Women consented (n=1335)
Usual care from health visitor
Women consented (n=2749)
In 63 clusters 1880/2749 (68.4%) returned 6
month EPDS; 234/1880 (12.4%) scored >12
In 37 clusters 995/1335 (74.5%) returned 6
month EPDS; 166/995 (16.7%) scored >12
In 37 clusters (1 lost to follow-up) 1172/1335
(87.8%) women returned 6 week EPDS
and 191/1172 (16.3%) had EPDS score >12
In 63 clusters 2277/2749 (82.8%)
women returned 6 week EPDS and
404/2277 (17.7%) had EPDS score >12
116/404 (28.7%) had no 8 week score and
115/288 (39.9%) had 8 week score >12
115+116 (231)/404 (55.8%) eligible for
sessions; 203/231 (87.9%) offered sessions
123/203 (60.6%); accepted >1 session
In 63 clusters 1745/2749 (63.5%) had 6 week
and 6 month score; 205/1745 (11.7%) scored >12
In 37 clusters 914/1335 (68.5%) had 6 week
and 6 month score; 150/914 (16.4%) scored >12
Of women with 6 week score >12, 271/404 (67.0%)
had 6 month score and 92/271 (33.9%) scored >12
Of women with 6 week score >12, 147/191 (77.0%)
had 6 month score and 67/147 (45.6%) scored >12
In 60 clusters (3 withdrew) 1118/1745 (64.1%) had 6
week to 12 month score; 105/1118 (9.4%) scored >12
In 37 clusters 593/914 (64.9%) had 6 week to
12 month score; 87/593 (14.7%) scored >12
Of women with 6 week score >12, 167/271 (61.6%)
had 12 month score; 40/167 (24.0%) scored >12
Of women with 6 week score >12, 94/147 (63.9%)
had 12 month score; 39/94 (41.5%) scored >12
In 60 clusters 652/1745 (37.4%)
had 6 week to 18 month data
In 37 clusters 291/914 (31.8%)
had 6 week to 18 month data
Of women with 6 week score >12,
89/271 returned 18 month data
Of women with 6 week score >12,
47/147 returned 18 month data
Fig 1 | Trial profile of clusters, all women and women with six week EPDS score ≥12 in control and
intervention groups. Note: 597 women were not sent 12 month questionnaire as their baby was
<12 months, and 1879 women were not sent 18 month questionnaire as their baby was not
18 months when follow-up interval ended
RESEARCH
page 2 of 10 BMJ | ONLINE FIRST | bmj.com

within the trial follow-up phase were sent a postal
follow-up questionnaire.
Intervention group
In clusters in the intervention group the psychologi-
cally informed approach comprised a package of
health visitor training, combining threemain elements
of assessing women, identifying depressive symptoms,
and delivering either a cognitive behavioural18 or a
person centred approach.19 A training reference group
of experienced academically based trainers in psycho-
logical therapy, who represented both the cognitive
behavioural and person centred approaches,
maximised the rigour, effectiveness, and comparability
of the two trainingprogrammes.Thiswas to ensure that
the trial would be considered by advocates of each
approach to have been a credible and fair test of that
approach. The manualised health visitor training
ensured that unintentional bias supporting either of
the two interventions was minimised and prepared the
health visitors to provide an appropriate, pragmatic,
distinctive, derivative approach, delivering critical
elements fromcognitivebehavioural therapyorperson
centred therapy, not psychotherapy.
The common areas for training in both approaches
enabled health visitors to acquire further generic skills
Table 1 | Baseline characteristics of women with score ≥12 on Edinburgh postnatal depression scale (EPDS) at six weeks
postnatally and all consented womenwho returned questionnaire at six weeks and six months, for intervention group (specially
trained health visitors) versus control group (usual care). Figures are means (SD) or numbers (percentages) of women
Women with six week EPDS score ≥12 (n=418) All women (n=2659)
Control Intervention All Control Intervention All
Age (years):
No of women 147 271 418 913 1745 2658
Mean (SD) 30.6 (5.5) 31.0 (5.4) 30.9 (5.4) 32.0 (5.1) 31.3 (5.0) 31.5 (5.1)
Age (years) at birth of first child:
No of women 145 265 410 889 1714 2603
Mean (SD) 27.5 (6.0) 27.4 (5.8) 27.4 (5.8) 29.0 (5.3) 28.0 (5.3) 28.4 (5.3)
No of other children:
No of women 147 271 418 914 1745 2659
Mean (SD) 0.7 (1.0) 0.8 (0.9) 0.8 (0.9) 0.7 (0.8) 0.7 (0.9) 0.7 (0.9)
EPDS score at six weeks:
No of women 147 271 418 914 1745 2659
Mean (SD) 15.4 (3.2) 15.1 (2.9) 15.2 (3.0) 6.8 (5.0) 6.6 (4.8) 6.7 (4.8)
CORE-OM score at six weeks:
No of women 146 269 415 906 1735 2641
Mean (SD) 1.40 (0.50) 1.35 (0.49) 1.37 (0.49) 0.55 (0.51) 0.51 (0.49) 0.52 (0.50)
SF-12 MCS score at six weeks:
No of women 143 265 408 888 1719 2607
Mean (SD) 29.4 (9.2) 29.1 (8.0) 29.2 (8.4) 42.7 (9.5) 42.9 (9.3) 42.9 (9.4)
SF-12 PCS score at six weeks:
No of women 143 265 408 888 1719 2607
Mean (SD) 48.5 (10.9) 50.1 (9.4) 49.6 (10.0) 50.5 (8.7) 51.4 (8.0) 51.1 (8.3)
Twin births 2/147 (1.4) 3/270 (1.1) 5/417 (1.2) 5/833 (0.6) 19/1727 (1.1) 24/2560 (0.9)
Living alone with no
adults
7/146 (4.8) 19/269 (7.1) 26/415 (6.3) 31/912 (3.4) 58/1706 (3.3) 89/2618(3.4)
History of major life
events
73/145 (50.3) 152/269 (56.5) 225/419 (54.3) 368/906 (40.6) 715/1735 (41.2) 1083/2641 (41.0)
White ethnicity 133/147 (90.5) 257/271 (94.8) 390/418 (93.3) 871/914 (95.3) 1686/1744 (96.6) 2557/2658 (96.2)
English first language 136/147 (92.5) 266/271 (98.2) 402/418 (96.2) 877/914 (96.0) 1699/1744 (97.4) 2576/2658 (96.9)
CORE-OM=clinical outcomes in routine evaluation-outcome measure; SF-12 MCS=short form 12 mental component summary; SF-12 PCS=short form 12
physical component summary. Better health represented by lower EPDS and CORE-OM score and higher SF-12 PCS and SF-12 MCS score.
Table 2 | Primary outcome: numbers (percentages) of women with score ≥12 on Edinburgh postnatal depression scale at six months among 418* women with
score ≥12 at six weeks, all women (n=2659*), and 2241 women with score <12 at six weeks
Control Intervention % Difference (95% CI)
Odds ratio (95% CI)
Unadjusted Adjusted†
Score ≥12 at six weeks 67/147 (45.6) 92/271 (33.9) 11.7 (0.4 to 22.9) 0.62 (0.40 to 0.97), P=0.036 0.60 (0.38 to 0.95), P=0.028
All women 150/914 (16.4) 205/1745 (11.7) 4.7 (0.7 to 8.6) 0.67 (0.51 to 0.87), P=0.003 0.67 (0.52 to 0.86), P=0.002
Score <12 at six weeks 83/767 (10.8) 113/1474 (7.7) 3.1 (0.4 to 5.9) 0.68 (0.51 to 0.92), P=0.016 —
*For adjusted odds ratio, n=409 for women with score ≥12 at six weeks and 2624 for all women.
†Adjusted for score at six weeks, living alone, history of postnatal depression, any life events.
RESEARCH
BMJ | ONLINE FIRST | bmj.com page 3 of 10

in developing helpful relationships such as positive
regard and empathy. The cognitive behavioural
training emphasised the identification of unhelpful
patterns of behaviours, perceptions, or thoughts in a
woman’s life, and that these are common and normal,
to help the woman to change these herself.18 The
person centred training used the three principles of the
actualising tendency, a non-directive attitude, and the
necessary and sufficient conditions of change.19 Person
centred counselling has previously been referred to as
non-directive counselling.25 See bmj.com for further
details on the training of the health visitors.
As usual in the application of psychologically
informed approaches in the NHS, the health visitors
had access to clinical supervision with the trainers by
telephone. The health visitors were asked to attend
monthly reflective practice sessions to ensure they
carried out the sessions according to their training.
Women eligible for psychologically informed sessions
In the intervention group the health visitors re-
administered the EPDS face to face at eight weeks
postnatally to all women with a six week EPDS score
≥12.Thosewho still had a score≥12wereoffered either
cognitive behavioural or person centred sessions
according to the cluster randomisation.
The health visitor delivered weekly one hour
sessions in the woman’s home for up to eight weeks,
focusing on the woman’s needs, starting around eight
weeks postnatally.
Usual care
In the UK, general practitioners, midwives, and
hospital obstetricians meet women early in pregnancy
to plan care. Care is then given by a midwife, shared
between the midwife and possibly a general practi-
tioner, or otherwise. Consultant led care is based on
clinical need. UK health visitors have routine contact
withwomen at a newbirth visit and atwell baby clinics.
Before random allocation, 47% of all participating
health visitors had used an EPDS assessment at six
weeks postnatally, according to primary care trust
policy, and would typically refer women to a general
practitioner but not offer psychologically informed
sessions.After randomisation, control health visitors in
38 clusters continued to represent this variability so
women in the control group continued to receive the
range of usual postnatal care as provided by these
health visitors. All health visitors continued to fulfil
other aspects of their role.
Outcomes
Wemeasured outcomes using a postal questionnaire at
six, 12, and 18 months postnatally.
Primary outcome—The patient centred primary out-
come was the proportion of women with a six week
EPDS ≥12, who had a six month EPDS score ≥12.
Secondary outcomes—Secondary outcomes included
themeanEPDS score at six and 12months postnatally.
The other secondary outcomes had all been used with
perinatal women and had good psychometric
properties.15 To capture the broader impact of the
intervention we measured women’s general health
using the SF-12 mental component summary (SF-
MCS) and physical component summary (SF-PCS).26
We used the clinical outcomes in routine evaluation-
outcome measure (CORE-OM)27 as a measure of
global distress. We also measured symptoms of
postnatal anxiety using the state-trait anxiety inventory
(STAI)28 because anxiety disorders are as common as
Table 3 | Secondary outcomes at six months for women with score ≥12 on Edinburgh postnatal depression scale (EPDS) at six weeks and all women, for control
group versus intervention group
Control Intervention Unadjusted Adjusted*
No of
women Mean (SD)
No of
women Mean (SD) Difference (95% CI) P value Difference (95% CI) P value
Women with score ≥12 at six weeks (n=418):
EPDS 147 11.3 (5.8) 271 9.2 (5.4) −2.1 (−3.4 to −0.8) 0.002 −2.1 (−3.3 to −0.9) 0.001
CORE-OM 146 1.05 (0.69) 269 0.82 (0.62) −0.23 (−0.39 to −0.07) 0.006 −0.22 (−0.36 to −0.09) 0.001
STATE anxiety 136 45.5 (12.5) 254 41.7 (11.8) −3.8 (−6.6 to 1.0) 0.008 −3.9 (−6.1 to −1.4) 0.003
SF-12 MCS 142 37.8 (11.8) 263 42.3 (10.8) 4.7 (1.8 to 7.6) 0.001 5.2 (2.5 to 7.8) 0.001
SF-12 PCS 142 54.3 (9.0) 263 53.0 (7.6) −1.4 (−3.5 to 0.7) 0.204 −1.7 (−3.6 to 0.1) 0.069
PSI-SF total
stress
106 139.6 (20.4) 211 148.9 (17.0) 9.2 (4.8 to 13.7) 0.001 9.3 (5.2 to 13.4) 0.001
All women (n=2659):
EPDS 914 6.4 (5.2) 1745 5.5 (4.7) −1.0 (−1.5 to −0.4) 0.001 −0.8 (−1.2 to −0.4) 0.001
CORE-OM 906 0.53 (0.53) 1736 0.45 (0.46) −0.09 (−0.15 to −0.04) 0.001 −0.07 (−0.11 to −0.03) 0.001
STATE anxiety 858 34.3 (11.7) 1634 33.2 (10.9) −1.3 (−2.7 to −0.1) 0.042 −1.3 (−2.5 to −0.1) 0.033
SF-12 MCS 885 47.6 (10.5) 1694 48.9 (9.5) 1.5 (0.3 to 2.6) 0.010 1.4 (0.5 to 2.3) 0.003
SF-12 PCS 885 54.5 (6.8) 1694 54.7 (6.1) 0.2 (−0.3 to 0.7) 0.469 0.0 (−0.4 to 0.5) 0.871
PSI-SF total
stress
698 155.9 (16.9) 1310 157.9 (15.3) 2.1 (0.3 to 3.9) 0.021 2.3 (0.6 to 3.9) 0.007
CORE-OM=clinical outcomes in routine evaluation-outcome measure; SF-12 MCS=short form 12 mental component summary; SF-12 PCS=short form 12 physical component summary; PSI-
SF=parenting stress index short form. Better health represented by lower score in EPDS, CORE-OM, and STATE anxiety; higher score in others
*Adjusted for six week score, living alone, history of postnatal depression, any life events.
RESEARCH
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depression after delivery.29 Women completed the
parenting stress index short form (PSI-SF)30 as a
measure of adjustment to new parenthood.
Recruitment and randomisation
We systematically approached a range of networks to
facilitate the recruitment of clusters. Health visitors
worked with the general practitioners, were usually
based in the same premises, and held a caseload of
families registeredwith the practice. To avoid selection
bias in the clusters, health visitors and a general
practitioner in each practice signed a consent form
before the random allocation. The health visitors
aimed to recruit all eligible individual women on
their caseload consecutively to avoid bias in the
selection of women.
Sequence generation and random assignment
An independent statistician generated the allocation
sequence using a computer randomisation programme
(RANDOM, Southampton University). To minimise
imbalance across groups, the clusters were stratified by
the number of expected births per cluster per year into
three groups (<70, 70-100, >100). Clusters were
allocated to either cognitive behavioural or person
centred approach (intervention) or the control group in
a ratio of 1:1:1.The sequencewas concealed to clusters.
The principal investigator (CJM) enrolled the general
practitioners and health visitors and informed them of
their allocation. We could not blind participants or
health visitors to group assignment.
Sample size calculation
Tocalculate the sample sizewe assumedan intracluster
correlation coefficient of 0.00631 and an average of six
women per cluster with a six week score ≥12. Eighty
seven clusters or 520 women with a six week score ≥12
(350 intervention, 170 control) would yield 90%power
at the 5% two sided level of significance to detect a 15%
absolute difference (50% v 35%) in the proportions of
women in each group with a six month score ≥12. We
assumed a 20% loss to follow-up at six months,
requiring 649 women in total and a recruitment
phase of 15 months. Within the intervention group
we also had 80% power to detect a 15% significant
difference in the proportions of women with a six
month score ≥12 (43% v 28%) between the two
intervention groups.
Statistical analysis
All analyses were by intention to treat, analysed as
randomised, irrespective of receipt of psychologically
informed sessions,with P<0.05 regarded as significant.
The primary analysis compared scores at six months
for women with a six week EPDS score ≥12 in all
intervention clusters with those in the control group.
We used a marginal generalised linear model with
coefficients estimated using generalised estimating
equations32 with robust standard errors and an
exchangeable auto correlation matrix in Stata v8
(StataCorp, College Station, TX) to analyse the
outcomes and adjust for the potential clustering of the
data. We have shown estimates of the group coeffi-
cients from these regression models with their asso-
ciated 95% confidence intervals. In all the analyses we
first fitted a simple model and then one to adjust for
individual level covariates (living alone, history of
postnatal depression, and stressful life events, as the
strongest predictors of postnatal depression)22 and six
week EPDS score. For secondary outcomes we
compared mean values at six, 12, and 18 months
using similar models. We included in the statistical
analysis women with EPDS scores at both six weeks
and six months and did not impute missing data.
RESULTS
Cluster characteristics
Figure 1 shows the flow of clusters and participants
through the trial. Among 241 interested practices, 101
consented to take part. These recruited practices were
in areas representative ofTrent andEngland as awhole
according to the index of multiple deprivation. 33 The
101 clusters yielded 7649 eligible women of whom
4084 (53%) with a live baby consented to take part.
Six week response and identification of women with six
week EPDS score ≥12
Of all the women in 101 clusters, 85% (3449/4084)
completed a six week questionnaire: 16% (191/1172)
in the control group and 18% (404/2277) in the
intervention group scored ≥12 on the EPDS.
Characteristics of women in the comparison groups
Table 1 compares the baseline characteristics of
women with a six week EPDS score ≥12 (n=418) and
all women (n=2659)who returnedquestionnaires at six
weeks and six months, indicating that the randomisa-
tion resulted in well balanced groups.
Table 4 | Primary outcome: numbers (percentages) of women with score ≥12 on Edinburgh postnatal depression scale at six
months among 418* women with score ≥12 at six weeks and all women (n=2659*) according to therapeutic approach:
cognitive behavioural (CBA) or person centred (PCA)
CBA PCA Difference % (95% CI)
Odds ratio (95% CI)
Unadjusted Adjusted
Score ≥12 at six
weeks
46/140
(32.9)
46/131
(35.1)
2.2 (−10.1 to 14.2) 1.09 (0.64 to1.88), P=0.74 1.00 (0.57 to 1.77), P=0.99
All women 98/848
(11.6)
107/897
(11.9)
0.3 (−2.6 to 3.4) 1.04 (0.78 to1.39), P=0.80 1.09 (0.81 to 1.46), P=0.59
*For adjusted odds ratio, n=265 for women with score ≥12 at six weeks and 1726 for all women.
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Six month follow-up and analysis for women with six
week EPDS score ≥12
Seventy per cent (418/595) of women with a six week
EPDS score ≥12 from 86 clusters had a six week and a
six month score available for analysis; 77% (147/191)
in the control group v 67% (271/404) in the inter-
vention group (fig 1). For the primary outcome, 46%
women (67/147) in the control groupand34%(93/271)
in the intervention group scored ≥12 on the six month
EPDS (table 2). The difference of 11.7% (95%
confidence interval 0.4% to 22.9%) was significant
(P=0.039). Thismeans that wewould need to treat nine
women who had a six week EPDS score ≥12 for one
additional woman to have an EPDS score <12 at six
months.
After adjustment for living alone, historyof postnatal
depression, stressful life events, and six week EPDS
score theodds ratio (0.60, 0.38 to 0.95, P=0.028) further
indicated that women in the intervention group with a
six week score ≥12 were 40% less likely to have a six
month score ≥12 than women in the control group.
For women with a six week score ≥12, the mean
EPDS score at six months was 11.3 (SD 5.8) in the
control group and 9.2 (SD 5.4) in the intervention
group (table 3). The mean difference of −2.1 (−3.4 to
−0.8, P=0.002) remained significant after we adjusted
for variables at sixweeks (P=0.001). Table 3 also shows
the differences in the mean scores for the secondary
outcomes in favour of the intervention group women
with a six week EPDS score ≥12.
Six month follow-up and analysis for all women as
randomised
Of all the women who returned a six week ques-
tionnaire, 77% (2659/3449) also returned a six month
questionnaire (fig 1): 78% (914/1172) in the control
group and 77% (1745/2277) in the intervention group.
At the six month follow-up 16% (150/914) of all
women in the control group and 12% (205/1745) of all
women in the intervention group had a six week score
≥12, an absolute difference of 4.7% (0.7% to 8.6%,
P=0.003). The difference was still significant (P=0.002)
after we adjusted for living alone, history of postnatal
depression, stressful life events, and six week EPDS
score (table 2). The mean score was 6.4 (SD 5.2) in the
control group and 5.5 (SD 4.7) in the intervention
group (P<0.001) (table 3). Table 3 also shows the
secondary outcome mean scores for all women
favouring the intervention group women.
Intracluster correlation coefficient
The observed intracluster correlation coefficient for
the primary outcome at sixmonths was 0.037 (0.000 to
0.114) for the 418 women with a six week score ≥12 in
86 clusters and 0.009 (0.000 to 0.022) for all 2659
women in 100 clusters.
Comparison of the cognitive behavioural approach and
person centred approach
Examination of the two intervention groups separately
showed that 33% (46/140) of women with a six week
score ≥12 in the cognitive behavioural group and 35%
(46/131) in the person centred group had a six month
score≥12 (P=0.74) (table 4). Themean sixmonth score
was 9.2 (SD 5.3) for women in the cognitive beha-
vioural group and9.2 (SD5.5) forwomen in the person
centred group (P=0.99).
For all women in the intervention group, 12% (98/
848) in the cognitive behavioural group and 12% (107/
897) in the person centred group had a sixmonth score
≥12 (P=0.80). The mean six month score was 5.5 (SD
4.7) for all women in each of the groups (P=0.94).
Secondary outcomes at 12 and 18 months
Figure 2 shows how themean score changed over time
fromsixweeks to 12months forwomenwith a sixweek
score ≥12 and all women by group. Table 5 shows that
the differences in the mean EPDS scores at six months
and secondary outcome scores were sustained at
12 months for the women with a six week score ≥12
and for all women. Table 6 shows that in some
measures, differences in secondary outcomes were
maintainedat the18month follow-up forwomenwitha
six week score ≥12 and for all women.
DISCUSSION
This pragmatic cluster trial provides new evidence34 of
the effectiveness of a package of training for health
visitors to identify symptoms of depression postnatally
and to provide psychologically informed sessions.35 In
the intervention group we found a reduction in
depressive symptoms in postnatal women asmeasured
by the Edinburgh postnatal depression scale and by
secondary outcomes at six and 12 months postnatally
amongwomenwith a six week EPDS score ≥12 as well
as among all women as randomised. It is important to
note that the comparisonwas between the intervention
group and a usual care control group, rather than a no
treatment control group.
There was also some evidence of a benefit in favour
of the intervention group for some of the secondary
Time (months)
M
ea
n
sc
or
e
0 2 4 6 8 10 12
0
5
8
10
12
15
2
Intervention, all women (n=1118)
Control, all women (n=593)
Intervention, women at risk (n=167)
Control, women at risk (n=94)
Fig 2 | Mean EPDS scores over time by intervention and control
group for women at risk (score ≥12 on EPDS at six weeks) and
for all women
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page 6 of 10 BMJ | ONLINE FIRST | bmj.com

outcomes at the 18 month follow-up. As fewer women
were sent a follow-up questionnaire at 18 months,
however, more uncertainty surrounds these outcomes.
Strengths of the study
The trial has good internal and external validity and,
with more than twice as many participants as the
previous largest study,36 provides more evidence than
before of the benefit of psychologically informed
approaches for women with postnatal depression.16
We followed postnatal women to 18 months, whereas
the final outcome in most previous studies of postnatal
depression was measured at one to three months
postnatally,12 and also incorporated an economic
evaluation.
We achieved the required number of clusters. The
characteristics of the practices collaborating in the
study were representative of those in England, indicat-
ing good external validity. The attributes of health
visitors are also probably generalisable. We estimated
that 50% of all eligible women might consent to take
part and 53% consented, even though recruitment
relied on another agency (the health visitors) rather
than researchers. The similar characteristics of the
women with a six week EPDS score ≥12 in the
intervention and control clusters indicate that the
stratified randomisation process was effective, impart-
ing good internal validity. We believe the women’s
characteristics were similar to those for women in
England, andwomen in this trialwere representative of
women experiencing postnatal depression in real
world primary care and typical of women who use
the service.
Of all the women, 17.3% (595/3449) scored ≥12 on
the six week EPDS, and the mean score for these
women was 15.2. It was inevitable that not all women
with a six week score ≥12 would be eligible for the
psychologically informed sessions as the study was
designed to filter out women with transient depressive
symptoms by the re-administration of the EPDS at
eight weeks postnatally.
Of the intervention group women with a six week
EPDS score ≥12 who completed the EPDS at eight
weeks, 60% (173/288) scored<12and thereforedidnot
fulfil the criterion for the psychologically informed
sessions. Not all women completed an eight week
EPDS according to the protocol, principally because
the woman declined or could not be contacted. Some
women were not assessed at eight weeks because the
health visitor was absent (sick or on holiday). In reality
health visitors might not always repeat the EPDS for a
rangeof practical reasons.Also, as in the realworld, the
“clinical judgment” of health visitors dominated the
decision to offer psychologically informed sessions,
without the benefit of an eight week score.37
We would need to treat nine women with a six week
EPDS score ≥12 for one additional woman to have an
EPDS score <12 at sixmonths. This number is derived
from the absolute risk and is moderately good in this
context. A small number needed to treat (NNT)—that
is, approaching one—indicates that a favourable out-
come occurs in nearly every person who receives the
treatment and in few patients in a comparison group.
Though a number needed to treat approaching one is
possible, they are almost never found in practice, but
small numbers needed to treat do occur in some
therapeutic trials.38
We are aware of no other trials of drug or
psychologically informed interventions in a homo-
geneous group of women that report proportions of
Table 5 | Secondary outcomes at 12 months for women with score ≥12 on Edinburgh postnatal depression scale (EPDS) at six weeks and all women, for control
group versus intervention group
Control Intervention Unadjusted Adjusted*
No of
women Mean (SD)
No of
women Mean (SD) Difference (95% CI) P value Difference (95% CI) P value
Score ≥12 at six weeks:
EPDS 94 10.6 (6.2) 167 8.1 (5.6) −2.5 (−4.3 to −0.9) 0.003 −2.4 (−4.1 to −0.7) 0.005
CORE-OM 94 1.00 (0.68) 167 0.75 (0.62) −0.26 (−0.44 to −0.08) 0.005 −0.21 (−0.38 to −0.04) 0.015
STATE anxiety 93 45.0 (13.2) 162 40.7 (12.6) −4.3 (−8.1 to −0.7) 0.019 −4.2 (−7.8 to −0.5) 0.025
SF-12 MCS 92 40.8 (10.9) 161 44.9 (10.9) 4.1 (1.3 to 6.9) 0.004 3.8 (1.0 to 6.6) 0.008
SF-12 PCS 92 54.1 (7.5) 161 53.9 (7.0) −0.2 (−2.0 to 1.7) 0.857 −0.4 (−2.0 to 1.3) 0.650
PSI-SF total
stress
90 140.7 (21.4) 156 148.7 (19.2) 8.0 (3.1 to 13.0) 0.001 8.1 (3.6 to 12.6) 0.001
All women:
EPDS 593 5.9 (5.2) 1118 5.0 (4.6) −0.9 (−1.5 to −0.3) 0.002 −0.7 (−1.1 to −0.2) 0.003
CORE-OM 593 0.51 (0.53) 1120 0.42 (0.46) −0.09 (−0.16 to −0.04) 0.001 −0.07 (−0.12 to −0.03) 0.001
STATE anxiety 580 33.7 (11.7) 1097 32.4 (10.7) −1.5 (−2.7 to −0.2) 0.019 −1.4 (−2.5 to −0.2) 0.020
SF-12 MCS 579 48.7 (9.8) 1099 49.9 (9.2) 1.1 (0.2 to 2.0) 0.013 0.9 (0.1 to 1.6) 0.022
SF-12 PCS 579 55.0 (6.4) 1099 55.0 (6.0) 0.0 (−0.6 to 0.8) 0.834 −0.2 (−0.8 to 0.5) 0.590
PSI-SF total
stress
558 155.6 (17.1) 1055 157.0 (15.6) 1.43 (−0.4 to 3.0) 0.137 1.1 (−0.3 to 2.7) 0.123
CORE-OM=clinical outcomes in routine evaluation-outcome measure; SF-12 MCS=short form 12 mental component summary; SF-12 PCS=short form 12 physical component summary; PSI-
SF=parenting stress index short form. Better health represented by lower score in EPDS, CORE-OM, and STATE anxiety; higher score in others.
*Adjusted for six week score, living alone, history of postnatal depression, any life events.
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BMJ | ONLINE FIRST | bmj.com page 7 of 10

womenwith six month scores ≥12. Two trials reported
EPDS scores at 12 and 13 weeks,12 39 and a third study
(that allocated to group using coded slips of paper
drawn from a bag) reportedBeck depression inventory
and Beck anxiety inventory at 12 weeks after the inter
vention.40
Limitations and potential sources of bias
One limitation in the interpretation of the results arises
from the differential loss to follow-up at six months
among the women with a six week score ≥12: 23% of
women (44/191) in the control group and 33% (133/
404) in the intervention group did not complete the six
month EPDS. In the control group there was no
difference between themean EPDS scores at six weeks
in those women who did (15.4) and did not (15.1)
complete a sixmonthEPDS.Thecorresponding scores
in the intervention group were 15.1 and 16.2. The
potential impact of this on our results is unclear,
although we did adjust the six month scores for the
baseline six week score.
Another limitation is our use of the threshold score
≥12 to assess the level of depressive symptoms at six
months postnatally. As the sensitivity of the Edinburgh
postnatal depression scale at this threshold is 86%, the
presence of these self reported symptoms might not
necessarily have met the psychiatric criteria for a
primary diagnosis of depression. Conversely, some
women with a score below the threshold of 12 might
have had symptoms of depression not included in the
EPDS (specificity 78%) or might have chosen to
conceal their symptoms.41
The mechanism of action is unclear because of the
improvement in the intervention group, despite the
unexpectedly low uptake of the psychologically
informed sessions. In the intervention group 404
women had a six week score ≥12, but 173 were not
eligible for sessions as they had an eight week score
<12. However, 49% (199/404) of women were offered
sessions and 60% (120/199) accepted. Of the 404
women, 271 (67%) returned a sixmonth questionnaire.
Of these, 46% (124/271)were offered sessions and 62%
(77/124) accepted. The median number of sessions
attended was four (interquartile range two to seven).
The women might have had practical reasons, such as
lack of time, for not accepting the sessions.42
We found a significant reduction in depressive
symptoms in all thewomen in the intervention clusters,
including the 2241 with a six week score <12, of whom
11% (83/767) in the control group and 8% (113/1474)
in the intervention group had a six month score <12.
These results suggest that non-specific effects of the
health visitor intervention were operating to generate
the improvement extending beyond the women with a
six week score ≥12. As this was a pragmatic rather than
explanatory trial,wecanonly speculate about the cause
of the positive outcomes.
Because the health visitor intervention combined
different training components, it is difficult to disen-
tanglewhich elementsmight have beenmore effective.
Importantly, the health visitors used their skills
acquired during training to assess women, identify
those with postnatal depressive symptoms, and offer
support and deliver specific psychologically informed
sessions. Health visitors have a unique opportunity to
engagewith all postnatalwomenon their caseload.The
unexpected effect might have arisen because the
training equipped the health visitors with the con-
fidence in their skills, which they were motivated to
generalise beyond the original protocol specification
for the women with a six week score ≥12.43 That is, as a
result of their training, health visitors in the inter-
vention group might have extended their enhanced
relationship skills, such as warmth and empathy,
Table 6 | Outcomes at 18 months for women with score ≥12 at six weeks on Edinburgh postnatal depression scale (EPDS) and all women, for control group versus
intervention group
Control Intervention Unadjusted Adjusted*
No of
women Mean (SD)
No of
women Mean (SD) Difference (95% CI) P value Difference (95% CI) P value
Score ≥12 at six weeks:
CORE-OM 47 0.95 (0.77) 88 0.78 (0.67) −0.17 (−0.45 to 0.11) 0.228 −0.08 (−0.27 to 0.10) 0.374
STATE anxiety 46 42.7 (14.5) 85 40.8 (14.5) −1.9 (−6.9 to 3.5) 0.521 −1.3 (−5.8 to 3.2) 0.578
SF-12 MCS 46 40.2 (7.1) 86 39.5 (5.4) −0.7 (−2.9 to 1.3) 0.463 −0.7 (−2.7 to 1.3) 0.509
SF-12 PCS 46 52.1 (12.9) 86 56.0 (8.6) 3.9 (1.1 to 7.1) 0.007 2.9 (−0.1 to 6.0) 0.062
PSI-SF total
stress
46 138.1 (23.2) 82 147.2 (21.2) 9.1 (1.1 to 17.4) 0.026 9.0 (1.6 to 16.4) 0.017
All women:
CORE-OM 291 0.54 (0.55) 650 0.43 (0.49) −0.11 (−0.18 to −0.03) 0.005 −0.07 (−0.13 to −0.02) 0.011
STATE anxiety 281 34.0 (11.8) 631 32.6 (10.8) −1.5 (−3.4 to 0.4) 0.116 −1.4 (−3.1 to 0.3) 0.105
SF-12 MCS 286 40.1 (5.7) 634 40.0 (4.8) −0.0 (−0.6 to 0.5) 0.875 −0.0 (−0.5 to 0.4) 0.846
SF-12 PCS 286 57.2 (10.1) 634 59.1 (7.2) 1.8 (0.6 to 3.1) 0.005 1.4 (0.2 to 2.6) 0.022
PSI-SF total
stress
276 153.0 (19.4) 628 156.3 (16.5) 3.3 (0.8 to 5.8) 0.009 3.2 (0.9 to 5.6) 0.007
CORE-OM=clinical outcomes in routine evaluation-outcome measure; SF-12 MCS=short form 12 mental component summary; SF-12 PCS=short form 12 physical component summary; PSI-
SF=parenting stress index short form. Better health represented by lower score in CORE-OM and STATE anxiety; higher score in others.
*Adjusted for six week EPDS score, living alone, history of postnatal depression, any life events.
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thereby improving engagement with all women on
their caseload antenatally and postnatally.
The intervention comprised other components,
which might also have affected the emotional status
of the new mothers. These were antenatal contact, the
early development of the mother-health visitor rela-
tionship, and emphasis on focusing on the woman
rather than solely the baby.
For those women who were offered but declined the
psychologically informed sessions, the knowledge that
thehealth visitorwas aware of their emotional state and
the offer in itselfmight have been perceived as support.
Having someone in whom to confide has been
identified as one of the main functional elements of
social support for coping with stressful situations, and
there is evidence of an association between absence of
such a close relationship and symptoms.44 The health
visitors remained in contact with women on their
caseload and there were opportunities for observation
and support when the women attended baby clinics,
baby massage, or postnatal groups. The women could
also ask for further follow-up support when they
thought they needed it.
The key to the effect of this psychological approach
might therefore lie in the generalisation of the training
outcomes across all women on their caseload, beyond
the scope for which the training was originally
developed, providing benefit from the health visitors’
enhanced input and ongoing supportive engagement.
Potential sources of bias
Over a third (46/125) of women in the control group
and over a quarter (61/214) in the intervention group
said they had been prescribed an antidepressant,
suggesting that the greater improvement in the inter-
vention group was not attributable to a higher rate of
prescriptions for antidepressants.
Contrasting benefits of psychologically informed
approaches
We found no difference in outcome between the two
psychological approaches. This finding is consistent
with findings of similar research on psychological
therapies that found that different models of inter-
vention result in broadly similar outcomes, despite
differences in theoretical bases and styleof intervention
delivered. This is known as the equivalence paradox.45
For example, a primary care trial for patients with
depression, comparing brief non-directive counselling
and cognitive behavioural therapy, found no signifi-
cant difference in outcomes at four months, leading to
the conclusion that they were both equally effective in
this setting to this follow-up point.7 Similar effects have
been found in large datasets comparing person centred
therapy and cognitive behavioural therapy in routine
NHS primary care settings.46
Further analysis and research
We report separately the results of further analysis for
the women with a six week EPDS score <12; infant,
partner, and economic outcomes; the views of women
using a qualitative approach; and features associated
with greater individual improvement.
The trial was not designed to detect the unexpected
non-specific effect of the training intervention on the
cohort of all women as randomised. This observation
should be tested in a trial focused on this issue to
determine the mechanism of the effect.
Conclusion
This large trial of treatment for postpartum depression
is unique in the comparison of the cognitive beha-
vioural approach and person centred approach. The
trial contributes new evidence to indicate that training
in psychologically informed approaches can be
recommended for health visitors to enable them to
identify postnatal depressive symptoms and enhance
the psychological care of postnatal women.
We thank the women, health visitors, general practitioners, and primary
care trusts for supporting the trial; the trial advisory group; Trent MREC,
David Shapiro, and the training reference group; Mike Campbell and the
data monitoring and ethics committee; Tom Ricketts, Keith Tudor, and
Chris Williams for their training input; Robin Smith, GIS Analyst; and Mind
Garden Inc for permission to use the STAI and Psychological Assessment
Resources for permission to use the PSI-SF.
Contributors: CJM prepared the proposal, designed and supervised the
conduct of the study, prepared the manuscript, and is guarantor. PS
prepared the proposal, advised on design and provided supervision for
the local coordinators. RW prepared the proposal and designed and
advised on the conduct of the study. GP advised on design and analysed
the intervention process monitoring. SD advised on design and
participated in the economic analysis and the reporting. SJW provided
statistical advice on the proposal at trial advisory group meetings and
revised the statistical analysis plan, analysed the data, contributed to the
writing. TB prepared the proposal and advised on design. MB advised on
design and chaired the trial advisory group. GJP advised on design and
planned the statistical analysis. JN contributed to the development of the
proposal, advised on design, and assisted with the preparation of the
manuscript. All contributors reviewed the manuscript.
Fundingandsponsor:The trial was commissioned, funded, and sponsored
by the NHS research and development health technology assessment
programme.
Competing interests: None declared.
Ethical approval: Trent multicentre research ethics committee.
Provenance and peer review: Not commissioned; externally peer
reviewed.
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Accepted: 14 October 2008
WHAT IS ALREADY KNOWN ON THIS TOPIC
Postnatal depression is a global problem that can persist beyond the first postnatal year
There are problems in recognising the condition and difficulties with using antidepressants in
postnatal women
Psychologically informed interventions provide a practical, acceptable alternative
WHAT THIS STUDY ADDS
Health visitors can be trained to develop skills in the assessment of women and the detection
of postnatal depressive symptoms and in the provision of psychologically informed
interventions based on person centred or cognitive behavioural principles
The training was effective in reducing the proportion of women with postnatal depressive
symptoms at six and 12 months postnatally
Bothpersoncentredandcognitive behavioural approacheswereequally beneficial inbringing
out sustained change in postnatal women
RESEARCH
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